Internet-based Treatment for Informal Caregivers in Lithuania LINGI

Caregiver Distress Clinical Trial

— LINGI  

Official title:

Internet-based Treatment for Informal Caregivers in Lithuania LINGI: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052724
• Other study ID #: LINGI
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2021
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Lithuania in reducing their care-giving burden.

Description:

Intervention is going to take a form of an Internet based Cognitive Behavioural Treatment program (ICBT) consisting of eight modules. These are the themes, as listed chronologically: Introduction, Thoughts, Stress and relaxation, Problem Solving, Communication, Anxiety, Behavioural Activation, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.

Effect of the intervention will be compared against a wait-list control group. Intervention is in Lithuanian.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2021
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• must be 18 years old or over

• fluent in comprehending, writing and reading Lithuanian language

• score 24 or more points on the Caregiver Burden Inventory

• spent at least last couple of months for providing care

• must have internet access and ability to use computer or any other compatible device

Exclusion Criteria:

• adverse life experiences as identified by LEC

• alcohol addiction

• having severe physical or mental impairments

• suicide risk

• severe interpersonal violence

• the person in need of care has life expectancy below or approximately around 6 months

Related Conditions & MeSH terms

• Caregiver Distress

Intervention

Behavioral:
• Intervention group LINGI
Intervention based on cognitive behavioural therapy principles and culturally adapted to Lithuanian population. Intervention's main purpose is to reduce caregiver burden and increase quality of life. Intervention contains psycho-educational elements as well as examples and exercises.

Locations

Country	Name	City	State
Sweden	Department of Behavioral Sciences and Learning, Linköping University	Linköping	Östergötland

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	University of Groningen, Vilnius University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life Events Checklist (LEC)	This measure will be used for screening for potentially traumatic events in respondent's lifetime. This questionnaire contains 16 questions and a box for mentioning any other stressful events experienced by an individual. There are 6 answer options for: 'Happened to me', 'Witnessed it', 'Learned about it', 'Part of my job', 'Not sure' and 'Doesn't apply'.	Pre-treatment
Other	The Alcohol Use Disorders Identification Test (AUDIT)	AUDIT will be used for assessing caregiver's alcohol consumption. It contains 10 questions in relation to the alcohol intake. Each question has varying answer options. Higher score indicates higher alcohol consumption and risks associated with it.	Pre-treatment
Primary	Change on Caregiver Burden Inventory (CBI)	This measure is used to evaluate caregiver burden. CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships. Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always'). Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced.	Pre-treatment, week 4, week 8 and 12 months post-treatment
Secondary	Change on Perceived stress scale (PSS-14)	Measure will be used to evaluate levels of experienced stress. It contains 14 questions on a Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Higher score indicates more severe symptoms.	Pre-treatment, week 8 and 12 months post-treatment
Secondary	Change on The Patient Health Questionnaire (PHQ-9)	Measure will be used to evaluate depressive symptoms. It contains 9 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.	Pre-treatment, week 4, week 8 and 12 months post-treatment
Secondary	Change on Generalized anxiety disorder (GAD-7)	Measure will be used to evaluate caregiver anxiety. GAD-7 contains 7 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.	Pre-treatment, week 4, week 8 and 12 months post-treatment
Secondary	Change on World Health Organisation (WHO-5)	This questionnaire contains 5 statements regarding individual's well-being. Each of the statements must be evaluated using 6-item Likert scale with a score of 0 indicating 'At no time' while a score of 5 - 'All the time'. Higher score indicates higher well-being.	Pre-treatment, week 8 and 12 months post-treatment
Secondary	Change on The Brunnsviken Brief Quality of Life Scale (BBQ)	BBQ will be used for evaluating overall quality of life. It contains 12 statements ranging on a Likert scale from 0 - 'Strongly Disagree to 4 - 'Strongly Agree'. Higher score indicates higher quality of life.	Pre-treatment, week 8 and 12 months post-treatment